RECRUITING

Anticoagulation in ICH Survivors for Stroke Prevention and Recovery

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Conditions

Intracerebral HemorrhageAtrial Fibrillation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Primary Aim: To determine if apixaban is superior to aspirin for prevention of the composite outcome of any stroke (hemorrhagic or ischemic) or death from any cause in patients with recent ICH and atrial fibrillation (AF). Secondary Aim: To determine if apixaban, compared with aspirin, results in better functional outcomes as measured by the modified Rankin Scale.

Official Title

Anticoagulation in Intracerebral Hemorrhage (ICH) Survivors for Stroke Prevention and Recovery

Quick Facts

Study Start:2020-01-28
Study Completion:2027-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03907046

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age at least 18 years
  2. * Intracerebral hemorrhage (ICH) (including primary intraventricular hemorrhage) confirmed by brain CT or MRI
  3. * Can be randomized within 14-180 days after ICH onset
  4. * Non-valvular AF (defined as atrial fibrillation or atrial flutter), documented by electrocardiography or a physician-confirmed history of prior AF
  5. * Provision of signed and dated informed consent form by patient or legally authorized representative
  6. * For females of reproductive potential: use of highly effective contraception
  1. * Index event is hemorrhagic transformation of a brain infarction or hemorrhage into a tumor
  2. * History of earlier ICH within 12 months preceding index event
  3. * Active infective endocarditis
  4. * Clear indication for anticoagulant drugs (e.g., requires anticoagulation for deep vein thrombosis or pulmonary embolism) or antiplatelet drugs (e.g., requires aspirin or clopidogrel for recent coronary stent).
  5. * Previous or planned left atrial appendage closure
  6. * Clinically significant bleeding diathesis
  7. * Serum creatinine ≥2.5 mg/dL
  8. * Active hepatitis or hepatic insufficiency with Child-Pugh score B or C
  9. * Anemia (hemoglobin \<8 g/dL) or thrombocytopenia (\<100 x 10\^9/L) that is chronic in the judgment of the investigator
  10. * Pregnant or breastfeeding
  11. * Known allergy to aspirin or apixaban
  12. * Concomitant participation in a competing trial
  13. * Considered by the investigator to have a condition that precludes safe or active participation in the trial
  14. * Persistent, uncontrolled systolic blood pressure (≥180 mm Hg)
  15. * ICH caused by an arteriovenous malformation (AVM) that has not yet been secured

Contacts and Locations

Study Contact

Kevin N Sheth, MD
CONTACT
443-615-4729
kevin.sheth@yale.edu
Hooman Kamel, MD
CONTACT
646-962-8284
hok9010@med.cornell.edu

Principal Investigator

Kevin N Sheth, MD
PRINCIPAL_INVESTIGATOR
Yale School of Medicine
Hooman Kamel, MD
PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University

Study Locations (Sites)

University of Alabama Hospital
Birmingham, Alabama, 35294
United States
University of South Alabama University Hospital
Mobile, Alabama, 36604
United States
Chandler Regional Medical Center
Chandler, Arizona, 85224
United States
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
United States
Banner University Medical Center
Tucson, Arizona, 85719
United States
UAMS Medical Center
Little Rock, Arkansas, 77205
United States
Mercy San Juan Medical Center
Carmichael, California, 95608
United States
Eden Medical Center, Castro Valley
Castro Valley, California, 94546
United States
Arrowhead Regional Medical Center
Colton, California, 92324
United States
Rancho Los Amigos National Rehabilitation Center
Downey, California, 90242
United States
Kaiser Permanente Fontana Medical Center
Fontana, California, 92335
United States
St. Jude Medical Center
Fullerton, California, 92835
United States
Long Beach Memorial Medical Center
Long Beach, California, 90806
United States
Los Alamitos Medical Center
Los Alamitos, California, 90720
United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
United States
Doctors Medical Center Modesto, Modesto, CA
Modesto, California, 95350
United States
Hoag Hospital Newport Beach
Newport Beach, California, 92663
United States
UC Irvine Medical Center
Orange, California, 92868
United States
Desert Regional Medical Center
Palm Springs, California, 92262
United States
Huntington Memorial Hospital
Pasadena, California, 91105
United States
Kaiser Permanente Redwood City Medical Center, Redwood City, CA
Redwood City, California, 94063
United States
UC Davis Medical Center
Sacramento, California, 95817
United States
Kaiser Permanente Sacramento Medical Center
Sacramento, California, 95825
United States
San Francisco General Hospital
San Francisco, California, 94110
United States
Stanford University Medical Center
Stanford, California, 94304
United States
PIH Health Hospital - Whittier
Whittier, California, 90602
United States
St. Mary's Medical Center
Grand Junction, Colorado, 81501
United States
Danbury Hospital
Danbury, Connecticut, 06810
United States
Hartford Hospital
Hartford, Connecticut, 06102
United States
Yale New Haven Hospital
New Haven, Connecticut, 06511
United States
New Hanover Regional Medical Center
Wilmington, Delaware, 28403
United States
MedStar Georgetown University Hospital
Washington, District of Columbia, 20007
United States
MedStar Washington Hospital Center
Washington, District of Columbia, 20010
United States
Morton Plant Hospital
Clearwater, Florida, 33756
United States
UF Health Jacksonville
Jacksonville, Florida, 32209
United States
Mayo Clinic
Jacksonville, Florida, 32224
United States
Jackson Memorial Hospital
Miami, Florida, 33136
United States
Ascension Sacred Heart Pensacola
Pensacola, Florida, 32504
United States
Cleveland Clinic Tradition Hospital
Port Saint Lucie, Florida, 34987
United States
Tampa General Hospital
Tampa, Florida, 33606
United States
St. Joseph's Hospital
Tampa, Florida, 33607
United States
Grady Memorial Hospital
Atlanta, Georgia, 30303
United States
Emory University Hospital
Atlanta, Georgia, 30322
United States
Augusta University Medical Center
Augusta, Georgia, 30912
United States
WellStar Kennestone Hospital
Marietta, Georgia, 30060
United States
The Queen's Medical Center
Honolulu, Hawaii, 96813
United States
NCH Hospital, Arlington Heights
Arlington Heights, Illinois, 60005
United States
Rush University Medical Center
Chicago, Illinois, 60612
United States
University of Illinois Hospital
Chicago, Illinois, 60612
United States
University of Chicago Medical Center
Chicago, Illinois, 60637
United States
Evanston Hospital
Evanston, Illinois, 60201
United States
Loyola University Medical Center
Maywood, Illinois, 60153
United States
OSF St. Francis Medical Center
Peoria, Illinois, 61637
United States
Javon Bea Hospital - Riverside
Rockford, Illinois, 61114
United States
St. John's Hospital
Springfield, Illinois, 62769
United States
Central DuPage Hospital
Winfield, Illinois, 60190
United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
United States
University of Kansas Hospital
Kansas City, Kansas, 66160
United States
Baptist Health Lexington
Lexington, Kentucky, 40503
United States
University of Kentucky Hospital
Lexington, Kentucky, 40536
United States
University of Louisville Hospital
Louisville, Kentucky, 40202
United States
Ochsner Medical Center - Main Campus
New Orleans, Louisiana, 70121
United States
Eastern Maine Medical Center
Bangor, Maine, 04401
United States
Tufts Medical Center
Boston, Massachusetts, 02111
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Boston Medical Center
Boston, Massachusetts, 02118
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Lahey Hospital & Medical Center
Burlington, Massachusetts, 01805
United States
Baystate Medical Center
Springfield, Massachusetts, 01199
United States
UMass Memorial Medical Center
Worcester, Massachusetts, 01655
United States
University of Michigan University Hospital
Ann Arbor, Michigan, 48109
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
McLaren Flint
Flint, Michigan, 48532
United States
Trinity Health Saint Mary's
Grand Rapids, Michigan, 49503
United States
Trinity Health Saint Mary's
Grand Rapids, Michigan, 49503
United States
McLaren Macomb
Mount Clemens, Michigan, 48043
United States
Munson Medical Center
Traverse City, Michigan, 49684
United States
Metro Health Hospital
Wyoming, Michigan, 49519
United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
United States
M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
United States
St. Cloud Hospital
Saint Cloud, Minnesota, 56303
United States
HealthPartners Methodist Hospital
Saint Louis Park, Minnesota, 55426
United States
Regions Hospital
Saint Paul, Minnesota, 55101
United States
United Hospital, St. Paul
Saint Paul, Minnesota, 55102
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216
United States
University of Missouri Health Care
Columbia, Missouri, 65212
United States
Barnes Jewish Hospital
Saint Louis, Missouri, 63110
United States
Mercy Hospital St. Louis
Saint Louis, Missouri, 63141
United States
Mercy Hospital Springfield
Springfield, Missouri, 65804
United States
Cox Medical Center South
Springfield, Missouri, 65807
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68105
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Overlook Medical Center
Summit, New Jersey, 07901
United States
Capital Health Regional Medical Center
Trenton, New Jersey, 08638
United States
University of New Mexico Hospital
Albuquerque, New Mexico, 87106
United States
Montefiore Medical Center
Bronx, New York, 10467
United States
Kings County Hospital Center
Brooklyn, New York, 11203
United States
NewYork-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, 11215
United States
Maimonides Medical Center
Brooklyn, New York, 11219
United States
NYU Langone Hospital - Brooklyn
Brooklyn, New York, 11220
United States
Buffalo General Medical Center
Buffalo, New York, 14202
United States
North Shore University Hospital
Manhasset, New York, 11030
United States
Mount Sinai West
New York, New York, 10019
United States
The Mount Sinai Hospital
New York, New York, 10029
United States
NYP Columbia University Medical Center
New York, New York, 10032
United States
NYP Weill Cornell Medical Center
New York, New York, 10065
United States
Vassar Brothers Medical Center
Poughkeepsie, New York, 12601
United States
Strong Memorial Hospital
Rochester, New York, 14642
United States
Staten Island University Hospital - North Campus
Staten Island, New York, 10305
United States
Stony Brook University Hospital
Stony Brook, New York, 11794
United States
SUNY Upstate Medical University
Syracuse, New York, 13210
United States
Westchester Medical Center
Valhalla, New York, 10595
United States
University of North Carolina Medical Center
Chapel Hill, North Carolina, 27514
United States
Carolinas Medical Center
Charlotte, North Carolina, 28204
United States
Moses H. Cone Memorial Hospital
Greensboro, North Carolina, 27401
United States
Forsyth Medical Center
Winston-Salem, North Carolina, 27103
United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
United States
Cleveland Clinic Akron General
Akron, Ohio, 44307
United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
United States
Good Samaritan Hospital
Cincinnati, Ohio, 45220
United States
UH Cleveland Medical Center
Cleveland, Ohio, 44106
United States
MetroHealth Medical Center
Cleveland, Ohio, 44109
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
OSU Wexner Medical Center
Columbus, Ohio, 43210
United States
Riverside Methodist Hospital
Columbus, Ohio, 43214
United States
OU Medical Center
Oklahoma City, Oklahoma, 73104
United States
Ascension St. John Medical Center
Tulsa, Oklahoma, 74104
United States
St. John Medical Center
Tulsa, Oklahoma, 74104
United States
Oregon Health & Science University Hospital
Portland, Oregon, 92739
United States
Providence St. Vincent Medical Center
Portland, Oregon, 97213
United States
PeaceHealth Sacred Heart Medical Center - RiverBend
Springfield, Oregon, 97477
United States
Jefferson Abington Hospital
Abington, Pennsylvania, 19001
United States
Lehigh Valley Hospital - Cedar Crest
Allentown, Pennsylvania, 18103
United States
Geisinger Medical Center
Danville, Pennsylvania, 17822
United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140
United States
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
Medical University of South Carolina University Hospital
Charleston, South Carolina, 29425
United States
Greenville Hospital System
Greenville, South Carolina, 29605
United States
Avera Research Institute
Sioux Falls, South Dakota, 57108
United States
Erlanger Health System
Chattanooga, Tennessee, 37403
United States
Fort Sanders Regional Medical Center
Knoxville, Tennessee, 37916
United States
Methodist University Hospital
Memphis, Tennessee, 38104
United States
Vanderbilt University Hospital
Nashville, Tennessee, 37232
United States
St. David's Medical Center
Austin, Texas, 78705
United States
UT Southwestern Medical Center
Dallas, Texas, 75390
United States
Baylor College of Medicine Medical Center
Houston, Texas, 77030
United States
Houston Methodist Hospital
Houston, Texas, 77030
United States
Memorial Hermann Texas Medical Center
Houston, Texas, 77030
United States
University of Texas Health Science Center San Antonio
San Antonio, Texas, 78229
United States
University of Utah Healthcare
Salt Lake City, Utah, 84112
United States
The University of Vermont Medical Center
Burlington, Vermont, 05401
United States
UVA Medical Center
Charlottesville, Virginia, 22908
United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042
United States
VCU Medical Center
Richmond, Virginia, 23298
United States
Virginia Mason Medical Center
Seattle, Washington, 98101
United States
Harborview Medical Center
Seattle, Washington, 98104
United States
Swedish Medical Center - Cherry Hill Campus
Seattle, Washington, 98122
United States
WVU Healthcare Ruby Memorial Hospital
Morgantown, West Virginia, 26506
United States
Froedtert Hospital
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Yale University

  • Kevin N Sheth, MD, PRINCIPAL_INVESTIGATOR, Yale School of Medicine
  • Hooman Kamel, MD, PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-01-28
Study Completion Date2027-04

Study Record Updates

Study Start Date2020-01-28
Study Completion Date2027-04

Terms related to this study

Additional Relevant MeSH Terms

  • Intracerebral Hemorrhage
  • Atrial Fibrillation